Journal of Medical Device Regulation Issue Headlines - August 2017

Guest Editorial: Can the US FDA be brought ‘back to the future’?

The 21st Century Cures Act was signed into law on 16 December
2016. Putting aside whether enough funds will be dedicated to enacting
Food and Drug Administration (FDA) policies, is this the legislation
that will bring the FDA back to its proper role of adjudicating safety
and effectiveness, that is, ‘back to the future’? In the view of this
author, the answer is ‘no’, and this article explores the reasons why. More >>

Guest Editorial: The challenges in implementing the new European
medical device and IVD Regulations

The Medical Devices Regulation and the In Vitro Diagnostics (IVD)
Regulation ((EU) 2017/745 and (EU) 2017/746, respectively) came into
force 20 days after their publication in the Official Journal on 5 May
2017. This marked the end of a very long road. It can be argued that the
origins of the new legislation began with concerns in 2001/3 involving
the recall of some total joint hip implants and the Trilucent breast
implants which used a soya based filler. The subsequent European
Commission consultation envisaged a major revision of the legislation,
but in the event this was not carried forward and a more limited
consolidation exercise was undertaken which resulted in Directive
2007/47/EU being agreed and enacted. The current Regulations have
involved detailed discussions involving seven European Member State
Presidencies and considerable debate. It was also necessary to invoke a
special ‘trilogue’ procedure involving the Member States, the European
Commission and the European Parliament to secure final agreement and
adoption. The new legislation is a significant departure from the
previous controls but the spirit of the ‘new approach’ is maintained, as
is the evaluation role of the Notified Bodies. This article provides a
brief overview of the new Regulations and looks at the UK’s situation
once it leaves the EU. More >>

Focus: A Competent Authority perspective on the new European medical
device and in vitro diagnostic legislation

On 5 May 2017, the European Commission published two new Regulations,
one for medical devices and one for in vitro diagnostics (IVDs),
to replace the current Directives which have been in place for over 25
years. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation
(EU) 2017/746 on IVDs (IVDR) will have staggered transition periods with
some aspects, such as the Notified Body requirements, becoming legally
binding after six months. The MDR will become fully applicable after
three years and the IVDR fully applicable after five years. Until then
the three Directives will remain in force. As the new legislation is in
the form of Regulations rather than Directives, the European law is
directly applicable at a national level without requiring transposition
through specific national legislation. This should allow for greater
legal certainty and help to prevent variation in the approach taken, or
in the rules that are applied across Europe. This article by the Health
Products Regulatory Authority (HPRA) in Ireland summarises the key areas
of change in the legislation, highlighting aspects particularly relevant
to manufacturers and to Notified Bodies. It also offers practical advice
for implementation by manufacturers and Notified Bodies, and points out
potential pitfalls for manufacturers. More >>

Focus: Economic Operators in the new European Regulations on medical
devices and in vitro diagnostics

Amongst many other requirements, Regulation (EU) 2017/745 on medical
devices and Regulation (EU) 2017/746 on in vitro diagnostics
define the obligations, responsibilities, legal aspects, standards
engagement and roles of all the Economic Operators (EOs) in the supply
chain. An EO is described as a manufacturer, an Authorised
Representative, an importer or a distributor. This concept is new
compared to the Directives; previously the recipients of the provisions
and responsibilities were the manufacturer and, for some aspects, his
Authorised Representative. Now, importers and distributors also receive
explicit mention and legal recognition of the obligations associated
with their roles. This article examines the general obligations that
apply to each of the EOs in the supply chain. More >>

Focus: Highlights of India’s 'Medical Devices Rules, 2017'

India published its first specific medical device regulations – the
Medical Devices Rules, 2017 – on 31 January 2017, and these will
come into force on 1 January 2018. At present, only a few medical
devices in India are regulated as drugs under the Drugs and Cosmetics
Act, 1940. As India is one of the largest medical device markets, it
has needed for some time a robust system for the regulation of medical
devices that takes into account the differences between medical devices
and drugs. The Medical Device Rules, 2017 will be applicable to
all the devices, in vitro diagnostics and other products covered
under various notifications from the Government of India (i.e. currently
regulated as drugs). However, the new Rules form the basis for the
regulation of all therapeutic medical devices and in vitro
diagnostics. Through the provision of clear timelines, fees and
procedures, India is expected to emerge as a well organised and
regulated medical device market. Also, the extensive similarity with
harmonised international requirements and standards, the transparency of
the system, and the use of online applications should ease the
transition process for medical device and in vitro diagnostic
manufacturers. This article summarises the main points of the new Rules. More >>

Country Overview: The medical device regulatory requirements in
Ecuador

At present, only about 130 medical devices are manufactured in
Ecuador, including cotton, gauze, vaginal speculums, sample collectors
and hospital beds; therefore, about 99% of medical devices used in the
country are imported. Ecuador has therefore needed to establish
regulatory control mechanisms to ensure the quality of medical devices
produced in the country as well as the quality of those that are
imported. This article presents a brief outline of the relevant
institutions, the legislation in force, and the processes for the
control of medical devices in Ecuador. It also describes the challenges
that the country and the Ecuadorian Association of Distributors and
Importers of Medical Products (ASEDIM) are currently facing. More >>

European News

EU: New Regulations on medical devices and in vitro
diagnostics finally published

EU: Products whose principal intended action (depending on PAC
present in cranberry) is to prevent or treat cystitis, should not be
medical devices